Phase I study of Vinorelbine(VNR) and S-1 combination therapy for the elderly patients with advanced non-small-cell lung cancer.

Phase I study of Vinorelbine(VNR) and S-1 combination therapy for the elderly patients with advanced non-small-cell lung cancer. - Phase I study of VNR and S-1 combination therapy.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000026093

Enrollment

Registered

2017-02-13

Start date

2017-02-21

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced non-small-cell lung cancer

Interventions

S-1 and Vinorelbine

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically confirmed Stage IIIB/IV non-squamous non-small cell lung cancer 2) 70<= years 3) No Previously treated chemotherapy 4) With one or more measurable disease based on RECIST (ver.1.1) 5) Performance Status (ECOG) : 0-2 6) Adequate function of vital organs, including normal hematopoietic liver and renal function as following: WBC >= 3,000/mm3 Neutrophils >= 1,500/mm3 Hemoglobin >= 9.0 g/dL Platelets >= 75,000/mm3 AST and ALT < 100IU/I Total bilirubin <= 1.5mg/mL Serum creatinine <= 1.5mg/dL PT-INR <1.5 Urinary protein <= 1+ 7) A life expectancy of more than 3 months 8) Written informed consent before initiation of study-related procedures

Exclusion criteria

Exclusion criteria: 1) Symptomatic brain metastasis 2) Severe infection 3) Severe comorbidity (heart failure Tendency to hemorrhages uncontrollable hypertension, uncontrollable diabetes, etc) 4)Interstitial pneumonia or pulmonary fibrosis detectable on X ray. 5) Planning of surgery or thoracic radiotherapy during the trial. 6) With a history of drug sensitivity for S-1 or Vinorelbine. 7) Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.

Design outcomes

Primary

Measure	Time frame
Recommended dose of S-1 and VNR combination therapy.	—

Secondary

Measure	Time frame
We evaluate the efficacy and safety of S-1 and VNR combination therapy for the elderly patients with advanced non-small-cell lung cancer.	—

Countries

Japan

Contacts

Public ContactMikio Takamori

Tokyo Metropolitan Tama Medical Center Department of respiratory medicine and clinical oncology

mikio_takamori@tmhp.jp042-323-5111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026